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PROTEUS Patient Summary
The PROTEUS study is a randomized, double-blind, placebo-controlled, phase 3 Study of an investigational drug in subjects with high-risk, localized or locally advanced prostate cancer who are candidates for radical prostatectomy.
WHY IS THIS CLINICAL RESEARCH STUDY BEING DONE?
Whilst a radical prostatectomy, which is surgery to remove the prostate gland and tissues surrounding it, is a common treatment for high-risk, localized or locally advanced prostate cancer, however, it doesn’t always stop disease progression.
As a result, medical researchers recognize the need to prevent reoccurrence of cancer, even after the prostate is removed. In the PROTEUS research study, doctors want to learn more about an investigational medicine that is taken with hormone therapy and given before and after a prostatectomy. They want to see if it is safe and if it is effective and helps prevent cancer from spreading when given to high-risk prostate cancer patients who choose prostate removal surgery as their treatment option.
All participants in this study will receive androgen deprivation therapy (ADT), which is used to reduce male hormone levels and stop them from affecting prostate cancer cells. ADT is commonly given to men for the treatment of prostate cancer. However, it is not currently given to patients before a prostatectomy unless they are in a research study.
In addition to ADT, patients will receive either the investigational drug or placebo (which looks like the investigational drug but contains no active medication)
The results of the PROTEUS study will provide more information about the investigational drug and their use in men who have high-risk prostate cancer and undergo prostate removal surgery.
Who is eligible to be in the PROTEUS study?
To pre-qualify for this study, you must:
- Be 18 years of age or older
- Have been diagnosed with locally advanced or localized high-risk prostate cancer
- Have talked with your doctor and decided to undergo prostate removal surgery
There are other qualifying criteria that your study doctor will be able to discuss with you in more detail. All study-required visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-required travel may be available.
To learn more about this study and to find out if you may be eligible, please visit:
Clinical Trials.gov Information
Contacts and Trial Site Locations
Janssen Global Trial Finder
Organization: Janssen Research & Development, LLC
PHEN Contact: 617-481-4020
* Please Note: This information is provided for education and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
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